GxP Lifeline

How Frances O. Kelsey Blazed a Trail for Women in Regulatory Compliance

3 November, 2016 Jon Beckstrand, CEO, MasterControl Inc.

President Kennedy awarded Kelsey

the federal government’s highest civilian service award in 1962.

Whether it’s the ibuprofen we take to remedy a headache or the world’s smallest pacemaker approved by the FDA earlier this year, we can rest assured that these medical products passed scientific scrutiny and complied with stringent regulations. We can thank a woman who blazed a trail at the FDA—Frances Oldham Kelsey—for raising the bar in compliance.

While doing research on the history of Good Manufacturing Practices (GMP) for a presentation I made, I came across the extraordinary story of Kelsey, who helped avert a medical disaster in the United States in the 1960s. On her second month on the job at the FDA, Kelsey reviewed the new drug application (NDA) for thalidomide, a sleeping pill widely used in Europe for morning sickness. It was supposed to be an “easy” assignment suitable for a rookie like Kelsey because the drug had been in the market overseas since 1957.

Averting a Medical Disaster

Kelsey, who had an M.D. and a Ph.D. in pharmacology, rejected the NDA. “The claims were not supported by the type of clinical studies that had been submitted,” she said in her published autobiographical reflections. “Many of them were more testimonials than scientific studies (1).”

In particular, the manufacturer failed to answer Kelsey’s most important question: “Is thalidomide safe in pregnancy?” Between 1960 and 1961, she received tremendous pressure from the company to approve the drug, but she didn’t budge. She was right. In November 1961, the news broke about severe birth defects in Germany that were directly linked to thalidomide (2).

The disaster affecting thousands of children in Europe and Kelsey’s work caught the attention of American policy makers who wanted to reform drug laws. President John F. Kennedy awarded Kelsey the President’s Medal for Distinguished Service in 1962, the federal government’s highest civilian service award.

Congress promptly passed the 1962 Drug Amendments (also known as Kefauver-Harris Amendments), which included GMPrequirements. For the first time, the government required manufacturers to prove that their products are safe before selling them in the marketplace. This law toughened up FDA inspections and required the reporting of adverse side effects (3).

Trailblazing in Compliance

After the thalidomide incident, Kelsey continued to blaze a trail at the FDA, assuming the top job in three different FDA branches throughout her 45-year career at the FDA. In 2010, she was inducted to the National Women’s Hall of Fame.

Kelsey came a very long way from her beginnings as a research assistant at the University of Chicago, where she suspected someone had mistaken her first name, Frances, for Francis. The job offer she received was addressed to “Mr. Oldham.”

“I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up,” she said. Mistake or not, she took the job, and the rest is history (4).

Women in Regulated Environments

We at MasterControl provide quality and compliance software and services to regulated companies, most of them life science organizations under the FDA jurisdiction. After learning about Kelsey, I wanted to find out how many women served as system administrators within our customer base. In a regulated environment, the sysadmin typically spearheads quality efforts or at least plays an important role in compliance.

We generated a report to find out. I was pleased to see that about 50 percent of sysadmins in companies using MasterControl software are women. The figure is higher than the national statistics which show that 39.2 percent of the 17 million employed as managers in 2015 were women (5).

The difference is noteworthy, considering that women have been historically underrepresented in the field of science. Kelsey, who died last year at the age of 101, would have been pleased to see a substantial number of women sysadmins even just within the MasterControl community.

As the National Women’s Hall of Fame says in its website, “Dr. Kelsey helped open the door to women in medical and scientific research by proving that women can compete at the top.” The organization noted that during Kelsey’s time, less than 10 percent of medical students and graduate students in her field were women (6).

Susan B. Anthony of Compliance

This is my way of shining the spotlight on this exceptional woman who is the Susan B. Anthony of regulatory compliance. Kelsey transcended many barriers and worked tirelessly to ensure the safety of medical products just as Anthony dedicated her life to raising the standards for women’s rights to advance equality.

Both women deserve to be honored for their pioneering efforts in their respective fields. Indeed Kelsey has earned her place in the National Women’s Hall of Fame in the company of Anthony and other great women.

Jon Beckstrand is responsible for the overall direction and vision of MasterControl. Since his leadership began in 2002, MasterControl has enjoyed robust growth, introduced an array of new solutions, continued the company's push for innovation, and advanced its position as a leading provider of quality management software and services for regulated companies.

Beckstrand began his career as general counsel for a developer of credit union software systems. He then worked as a software-focused strategy and transactions consultant for KPMG in Chicago and Silicon Valley. He received a bachelor's degree in accounting from the University of Utah and a law degree from Brigham Young University and is a member of the Utah State Bar.